CompletedNot Applicable

Bi-level Erector Spinae Plane Block and Pre-emptive Oral Tizanidine for Analgesia After Mastectomy Surgery

Egypt90 participantsStarted 2025-07-15

Plain-language summary

Effective management of postoperative pain in breast cancer surgery is essential to minimize the risk of developing postmastectomy pain syndrome.The aim of this study is to evaluate the effectiveness of combining bilevel erector spinae plane (ESP) block with a single preoperative oral dose of tizanidine in improving postoperative analgesia in patients undergoing mastectomy surgery. It is hypothesized that the combination of bilevel ESP block and single-dose oral tizanidine will provide superior postoperative analgesia compared to bilevel ESP block alone in patients undergoing mastectomy.

Who can participate

Age range18 Years – 65 Years

SexFEMALE

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Inclusion criteria

✓. American Society of Anesthesiology (ASA) ІІ patients.
✓. Scheduled for unilateral modified radical mastectomy.
✓. BMI levels between 18.5- 35 Kg/m2.

Exclusion criteria

✕. Patient's refusal.
✕. Altered mental status or un-cooperative patients.
✕. History of known sensitivity to the used anesthetics.
✕. Bleeding or coagulation diathesis.
✕. Infection or redness at the injection site.
✕. Cardiac, renal, hepatic, hematological disease, peptic ulcer, gastrointestinal bleeding, and central or peripheral neurological disease.
✕. Chronic pain.
✕. Participants used analgesics routinely within the last 24 h.

What they're measuring

First analgesic request

Timeframe: Up to 24 hours after the procedure.

Trial details

NCT IDNCT07022353

SponsorMansoura University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-30

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